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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, diagnostic radiology
510(k) Number K152030
Device Name Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Applicant
Qingdao Hisense Medical Equipment Co., Ltd.
Software Outsourcing center 3rd floor north wing
No. 169 Songling Road, Laoshan
Qing dao,  CN 266101
Applicant Contact Liu Zhitang
Correspondent
Qingdao Hisense Medical Equipment Co., Ltd.
Software Outsourcing center 3rd floor north wing
No. 169 Songling Road, Laoshan
Qing dao,  CN 266101
Correspondent Contact Liu Zhitang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/22/2015
Decision Date 09/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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